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lab testing
Innovations in Lab Testing Arriving at Light Speed
By R. Lewis Dark | From the Volume XXXII, No. 4 – March 10, 2025 Issue
TODAY, IT’S A CHALLENGE TO STAY UP WITH ALL THE NEW THINGS arriving in the lab testing marketplace. Novel assays are launched weekly. That is equally true for next-generation automation and lab analyzers, with vendors regularly announcing something new to their menu of products. The pace of innova…
Payers Request More Claims Documentation
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Both anecdotal evidence from lab professionals and numbers-based data from XiFin point to a problem: More payers require clinical labs to produce more documentation that a test claim i…
Kaiser-Geisinger Acquisition Sets Stage for More Deals
By Robert Michel | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Even as experts were predicting more consolidation among multi-hospital health systems at the Executive War College in New Orleans last month, acquisition of Geisinger Health by Kaiser …
Lab Execs Allegedly Lied to FDA about Faulty Tests
By Scott Wallask | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…
COVID-19: a Fork in the Road for Future Lab Testing?
By R. Lewis Dark | From the Volume XXIX, No. 4 – March 14, 2022 Issue
We have all experienced a pandemic unique in the history of the world. Two elements, in particular, distinguished this pandemic from earlier global outbreaks. First, genetic technologies allowed scientists to almost instantly sequence the DNA of the novel coronavirus, once it was recognized as a uniq…
New Primary Care Providers May Change Who Buys & Who Orders Lab Tests
By Robert Michel | From the Volume XXVIII, No. 8 – June 14, 2021 Issue
This is an excerpt of a 2,445-word article in the June 14, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new playe…
MedPAC Advises Congress on Lab-Data Reporting
By Robert Michel | From the Volume XXVIII, No. 8 – June 14, 2021 Issue
CEO SUMMARY: For years, the clinical lab industry has sought unsuccessfully to get the federal Centers for Medicare and Medicaid Services to address the inequities in the payment formula CMS adopted after Congress passed the Protecting Access to Medicare Act (PAMA). In April, the la…
New Players May Alter Who Buys & Who Orders Lab Tests
By Robert Michel | From the Volume XXVIII, No. 8 – June 14, 2021 Issue
CEO SUMMARY: This first installment in our series describes why market forces are at work to create a new player in healthcare that will transform the lab testing marketplace as we know it today in two ways. First, a new category of primary care providers has the potential to eventu…
Getting Payer Coverage for New Tests Continues to Be Difficult
By Robert Michel | From the Volume XXVIII, No. 8 – June 14, 2021 Issue
EVERY YEAR, IT BECOMES TOUGHER FOR CLINICAL LABORATORIES WITH NEW GENETIC AND OTHER TESTS to obtain favorable coverage decisions by government and private payers. Not only does it take longer to get a decision from a payer, but payers today want to see …
Predicting Future Demand for COVID-19 Testing
By Robert Michel | From the Volume XXVIII, No. 7 – May 24, 2021 Issue
CEO SUMMARY: After 15 months of the pandemic, the nation’s clinical laboratories are at an interesting crossroads. Is the COVID-19 outbreak diminishing and close to disappearing? Or might it intensify again, particularly when the traditional influenza season arrives next fall? The…
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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